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Information for manufacturers of medical devices on post-market surveillance, reporting adverse incidents and field safety corrective actions to the MHRA.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
How to ensure the products you make or import comply with the law and are safe for consumers to use.
The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
How to apply for an authorisation to manufacture authorised veterinary medicines or medicines marketed under the Exemptions for small pet animals.
Apply to become or identify an approved manufacturer authorised to carry out conformity assessment.
How to apply for, update and cancel licences for the manufacture, import and wholesale of human and veterinary medicines.
Forms to make a variation to a manufacturer's licence.
UK guideline on GMP for decentralised manufacturing, ensuring compliance with EU GMP principles for safe, quality medicinal products.
Managing waste, health and safety, regulations
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